Job Description

QPPV EU (Associate Medical Director)

This is a rare opportunity to join a young, exciting science driven pharmaceutical company.

Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research. The company has a newly created vacancy for an experienced Pharmacovigilance Associate Director.

The Associate/Medical Director will have the following specific responsibilities in a team-oriented environment:

Conducts medical investigation for the individual case safety reports (ICSRs), including identifying appropriate follow-up requests of important medical information for the proper medical assessment and evaluation of the case report.

Ensures the ICSRs are medically accurate, complete, with the appropriate coding for the events (MedDRA coding), causality assessment, seriousness, and expectedness criteria for the case reports

Leads the evaluation and preparation of response documents of safety signals to answer internal and/or regulatory requests, and in the preparation of position papers for development and marketed products.

Assists the Head, CSPV with resource planning and management, and setting of group strategy and vision.

Mentors and trains PV and staff on new initiatives, regulatory changes and new processes.

Work on/manage special projects as directed.

Minimum Basic Qualifications:

MD with 3 years PV experience (5 years for Medical Director), or PharmD with 4 years PV experience (6 years for Medical Director.

Competencies:

Ability to leverage a deep understanding of oneself through knowing one’s strengths and weaknesses, proactively asking for feedback to balance self-perception, and being resilient to increase one’s effectiveness

Ability to demonstrate belief in one’s convictions by having the integrity to express oneself to one’s peers and superiors during increasingly challenging circumstances.

Ability to focus on delivering excellent results and improving the performance of oneself and of company by taking initiative to try new approaches, while still following the rules (e.g., company, government and ethical), by taking action to surpass one’s own past performance, excel at an objective measure or goal, or do something that has never been done before.

Ability to demonstrate respect for others by seeking to understand how they think about issues and perceive problems and opportunities.

Ability to express ideas and information clearly and accurately.

Ability to work cooperatively with colleagues and take initiatives to build relationships despite differences in interest, offering support and help to peers without being asked or proactively seeking input from others to solve problems

About

The RFT Group, are an Irish recruitment agency specialising exclusively in the recruitment of scientists, engineers and executives for the pharmaceutical, biopharmaceutical and medical device sectors across Ireland, Europe and Rest of World.